As the eClinical industry thrives, it’s easy to imagine the wisdom of EDC catching on and a new, paperless norm being established. After all, the burdens of paper-based data management–high cost, slow study build, and cumbersome SDV, just to name a few–have been well-documented on this very blog. With the superiority of EDC so far beyond dispute, shouldn’t paper be, by now, more or less a thing of the past?
The reality, of course, is that despite all this, paper records are still a fundamental component of clinical research. Even if a CRO uses EDC software in their trials, they still typically gather patient data on paper first and transfer it into the software later. Moreover, even after the data is safely recorded in the software, researchers still can’t indulge in the catharsis of the paper shredder; the paper must be stored for purposes of source document verification. The amount of paper at play here can be staggering. The average drug application is supported by numerous clinical trials and must include data from all of them. This can amount to up to six million pages–for reference, this is the weight equivalent of about ten Chevy Tahoe pickup trucks–for a single application1.
Indeed, despite all the progress EDC has made in diminishing the role of paper in clinical trials, and all the savings in time and cost that have been achieved as a result, the fight isn’t over. Paper has stubbornly found a way to stick around.
The good news is that eSource could come closer than ever to finishing the job. Only with eSource can data be collected electronically without any paper-based intermediary step. ePRO, eSignatures, and other technologies can cut paper completely out of a great number of clinical processes. The benefits of adopting this technology are clear throughout the clinical research field all the way up to the FDA, which in 2013 published an official set of guidelines for utilizing eSource efficiently, transparently, and in compliance with new and existing regulations2.
The next few years will offer an indication of how fast eSource catches on, and if it proves capable of making paper all but obsolete in clinical trials. Currently, though, EDC companies providing eSource as part of a larger repertoire of products are relatively uncommon. Medrio, which is in the midst of rolling out a suite of eSource-equipped products packaged under the name mSource, is an outlier in this regard. For Medrio, mSource represents the latest step–and, possibly, the boldest yet–in our ongoing campaign against paper.
1 Guerry, Pem; A Look at Independent E-Signatures to Limit the Paper Burden in Clinical Trials; Applied Clinical Trials; 8/31/2015
2 U.S. Dept of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health; Guidance for Industry: Electronic Source Data in Clinical Investigations; fda.gov; Sept. 2013